ML20031E436
| ML20031E436 | |
| Person / Time | |
|---|---|
| Site: | 07100466 |
| Issue date: | 09/01/1981 |
| From: | Hedlund R, Jerrica Johnson, Peters M MINNESOTA MINING & MANUFACTURING CO. (3M CO.) |
| To: | |
| Shared Package | |
| ML20031E435 | List: |
| References | |
| 19746, NUDOCS 8110150537 | |
| Download: ML20031E436 (50) | |
Text
Static Control Systems /3M TCAAP 590 New Bnghton. MN' 55112 7,
.b OVALITY PLAN 85-1.32 Type B Radioactive Material Containers 1 Sep 1981 I
MAfiUAL INDEX
1.0 INTRODUCTION
2.0 QUALITY PANUAL I
3.0 ORGANIZATION i
4.0 VENDOR PURCHASE ORDER 5.0 INSPECTION 6.0 C0tJTROL - STORAGE - SHIPMENT 7.0 CALIBRATION 8.0 RECORDS 9.0 AUDITS 10.0 TRAINING 11.0 APPENDICES l
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Reviewed By: g g Prepa y
R.R. Hedlund M.R. Peters-O
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Approved By
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Static ControlSystems 3M TCAAP 590 Nea Bngmon. MN 55112 ib 85-1.32 QUALITY PLAN 1 Sep 1981 0
1.0 If4TRODUCTION t
The purpose of the Quality Manual is to provide a working document for all l
groups at New Brighton describing responsibilities, procedures, systens and j
controls to meet quality assurance requirenents for Type B radioactive mate-i j
rial transport containers.
In addition, it is the intent of this program to meet the relevant require-ments of 10 CFR 71, Appendix E.
It is the responsibility of the supervisor of each group involved with the container to follow the requirenents of this Quality Manual and to inform and train the personnel in the uses of these procedures and systems, and to review the work of the group to assure compliance with all requirenents.
The program specifically applies to the transportation packages owned or I
rented by 3M Static Control Systens for which NRC approved certificates have been issued and for any other equiprent designated by the Plant Manager.
In particular, this program applies to the transportation packaces identified l
as follows:
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DOT Specification 3M Designation Owned By 55 M Container 3M m
6M R Container 3M (d
l 6679 Half Super Tiger U.S. Ecology i
i When Static Control Systems purchases, rents or repairs containers to be used as Type B conta'ners, and the testing is to be pcrformed by the ap-proved vendor, a detailed inspection plan will be prepared at the direction of the Quality Control Supervisor.
The supplier shall be inspected to ensure compliance with, or equivalency to, Section 5.0 of this manual.
2.0 QUALITY MANUAL 2.1 Scope 2.1.1 It is the purpose of this section to define the responsibility for the preparation, maintenance and control of this manual.
2.2 Responsibility l
2.2.1 This manual will be prepared by the Health Physics Supervisor and will be maintained and reviewed by the Quality Control Suoervisor prior to submis-sion for management approval.
2.3 Distribution 2.3.1 Numbered controlled copies of this manual shall be distributed to all Manage-l ment and Supervisory personnel who are involved in its implenentation and other personnel approved by the Plant Manager.
p 2 3.2 Uncontrolled copies may be distributed to other persens only upon approval V
of the Plant fianager.
Such copies will not be updated.
Form 20419 PWO
Static ControlSystems 3M TCAAP 590 m
New Bngnton. MN 55112 85-1.32 QUALITY PLA!i 1 Sep 1981 2.4 Revisions 2.4.1 The Quality Manual will be revised when significant changes occur in the quality system.
2.4.2 The contents of the Quality Manual will be reviewed annually, or more frequently if required, for updating.
2.4.3 Changes shall be reviewed and approved by the Plant Panager and Isotope Committee Chairman.
- 2.5 Records 2.5.1 The Quality Control Supervisor or designee shall maintain a file of the individual to whom each controlled copy is furnished.
The record shall include name, copy number, revision number and record of revisions issued.
l A record shall also be kept of distribution of uncontrolled copies.
3.0 ORGAt4IZATI0fi FOR QUALITY ASSURA!4CE 3.1 flew Brighton, Minnesota Plant Management All operations conducted in 3M's f;ew Brighton Plant are under the juris-diction of the Static Control Systens Department Plant Manager.
3M's (7
Medical Products Division also manufactures products in the Static Control V
Sys ems Department flew Brighton Plant.
All safety programs are administered by the Static Control Systems Department.
Health physics coverage is pro-vided by Static Control Systers Department personnel.
The organization chart for the New Brighton, Minnesota Plant is shown in Figure 1.
Tne responsibilities for those individuals directly involved with radionuclide source production and transportation are given below.
3.1.1 New Brighton Plant Manager As is the case in all 3M plants, the overall safety responsibilities for the production activities conducted at the New Brighton Plant rest with the Plant Manager.
Such responsibility is delegated to him by 3M Corporate management.
Included in these responsibilities is the Radiation Safety Program.
The Plant Manager is also the New Brighton Plant Radiation Safety Officer (R50) and, as such, is responsible for:
- 1. Seeing that the established Radiation Safety Program is properly implemented and maintained.
- 2. Auditing the activities of Production Supervisory personnel and employees to assure compliance with the established Radiation Safety Program.
- 3. Ascertaining that adequate training has been provided for each employee with respect to job requirements.
- 4. Advising 3M Health Physics Services and the 3M Isotope Committee of deficiencies and problems.
%Y 1
Form 20419 PWO
Static Control Systems'3M TCAAP 590 New Bnghton. MN 55112 7
N.,0 3
QUALITY PLAN 981 i
3.1.1.1 Health Physics Supervisor The Health Physics Supervisor reports to the Plant Manager and has the I
responsibility for the New Brighton Plant day-to-day operational Radiation Safety Program.
He is provided with a Health Physics staff, and the neces-sary facilities, equipment, and raterial to carry out the sampling, monitor-ing and other Health Physics functions required by the established Radiation I
Safety Program.
Details of the activities are found in Part 11 of Section IV l of the 3M Health Physics Manual.
3.1.1.2 fluclear Operations Superintendent The Nuclear Operations Superintendent reports to the New Brighton Plant Manager.
He has overall responsibility for production of products contain-int radionuclides.
Three personnel report to him as outlined below.
j 3.1.1.2.1 Production Supervisor sRadiation Source Droduction)
The Radiation Source Production Supervisor reports to the Nuclear Operations l
Superintendent and is responsible for the production activities associated 1
with Cs-137 medical and industrial sources, Kr-85 sources, Sr-90 industrial and medical sources, Co-60 industrial sources, and Pm-147 sources.
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3.1.1.2.2 Production Supervisor (Static Eliminator Production)
The Static Elininator Production Supervisor reports to the Nuclear Operations Superintendent.
His rain responsibilities are for the production of static eliminator devices containing Po-210.
l 3.1.1.2.3 Process Technologist (Microschere Production)
The Process Technologist reports to the Nuclear Operations Superintendent.
I He is responsible for incorporation of Co-60, Sr-90, Cs-137, Pm-147 and Po-210 activity into 3M Microspheres.
He is also responsible for the Po-210 extraction process.
3.1.1.3 Quality Control Supervisor The Quality Control Supervisor reports to the New Brighton Plant Manager.
He is responsible for the Quality Control Program associated with purchase i
l of materials and the Static Control Systems Department products which are i
marketed.
i Materials Control Supervisor l
l3.1.1.4 1
The Materials Control Supervisor reports to the New Brighton Plant Manager.
l l
He is responsible for packaging, shipping, receiving, procurement and in-l ventory control.
3.1.1.5 Plant Manager, Medical Products Division The Plant Manager of the Medical Products Division is responsible for the i
production activities involving use of Sc-46, Cr-51, Sr-85, Nb-95, Ce-141, o
I-125 and Yb-169.
He is responsible for carrying out all the safety pro-l C
!l grams established by the Static Control Systems New Brighton Plant Manager.
F orm 20419 PWO
Static Control Systems 3M TCAAP 593 New Brigrion. MN 55112 85-1.32 QUALITY PLAN 1 Sep 1981 3.1.1.5.1 Production Supervisor (Chelate, Tracers and Cs-137 Therapy) i j
This individual is responsible for production activities associated with l
Yb-169 chelate, tracer microsphere and Cs-137 therapy sources.
He r eports to the Plant Manager, Medical Products Division.
i 3.1.1.5.2 Production Supervisor (Instant Kit and I-125 Seeds) l This individual reports to the Plant Manager, Medical Products Division, i
and is responsible for production activities involving the nanufacture of 1-125 seeds and nonradioactive instant kits.
j 3.2 Medical Department, Health Physics Services l
I Health Physics Services is a part of the 3M Medical Department (See Figure
- 2) which (1) establishes and audits Radiation Safety Programs wherever sources of ionizing and nonionizing radiation are used within 3M; and (2) serves as a central coordinating group for 3M's licensing and registration activities for these radiation sources.
These responsibilities were es-i tablished by the 3M Corporate Management Committee in 1959.
Overall responsibility rests with the Manager, Health Physics Services, l
who has been designated the 3M Corporate Radiation Safety Officer.
Respon-c sibility for the New Brighton Plant Radiation Safety Program has been b) i delegated to the Manager, Ionizing Radiation, Health Physics Services.
Other Health Physics Services Health Physicists assist in the fulfillment of these responsibilities. One of these is assigned to the New Brighton Plant as Resident Health Physicist.
Specific Health Physics Services responsibilities are listed below:
- 1. Process and maintain USNRC Byproduct Material License 22-00057-06.
- 2. Assist the New Brighton Plant RSO and Health Physics Supervisor in the fulfillment of their responsibilities.
- 3. Audit activities in the New Brighton Plant to ensure that the established Radiation Safety Program is in compliance with the provisions of USNRC Byproduct Material License 22-00057-06.
- 4. Advise the Plant RSO and Isotope Committee of deficiencies and problems.
- 5. Perform a formal quarterly audit on health physics records and report I
the findings to the Isotope Committee.
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- 6. Develop, maintain and test emergency procedures.
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- 7. Provide health physics input on facility and procedure modifications.
- 8. Investigate and solve special health physics problems.
- 9. Develop and assist in implementation of the employee training program.
3.3 Isotope Committee l
(vl 3.3.1 Membership The Isotope Committee consists of the following eight members:
Form 20419 PWO
Static Control Systems 3M TCAAP590 New Bnghton. MN 55112 7
e 3
85-1.32 QUALITY PLA!i 1 Sep 1981 i
i l
- 1. Manager, Health Physics Services, Medical Department i
- 2. Manager, Static Control Systems Department
- 3. Production fianager, Static Control Systems Department i
- 4. Manager, Ionizing Radiation, Health Physics Services, fiedical Department
- 5. Plant Manager, Static Control Systems Department, fiew Brighton Plant
- 6. Plant Manager, Medical Products Division, flew Brighton Plant i
- 7. fiew Brighton Plant Resident Health Physicist, as assigned by Health i
Physics Services, f'edical Department
- 8. Manufacturing Engineering Manager, Static Control Systems The Manager of Health Physics Services is the Committee Chairperson.
3.3.2 Responsibilities The Isotope Committee is responsible for establishing an effective Radiation l
Safety Program for the Static Control Systems flew Brighton Plant and, through constant review, ensuring that it is implemented and maintained (see Figure 2).
In fulfilling this responsibility, it is committed to a policy of I
maintaining radiation exposures and releases of radioactive materials in I
i (m) i effluents to unrestricted areas as low as is reasonably achievable (see i
USf1RC Regulatory Guide 8.i0).
The Isotope Committee operates in accordance with the following guidelines:
- 1. The Committee appoints a Plant Radiation Safety Officer (RS0) who is i
responsible to the Comittee for implementing the Radiation Safety Program it establishes for the fiew Brighton Plant.
Presently the appointed RS0 is the Static Control Systems Department flew Brighton Plant Manager who has authority to halt any operation which he determines to present a radiation hazard to workers or the public.
- 2. The Committee specifically reviews operations under UStiRC License 22-00057-06 to:
- a. Evaluate and approve procedures for air sampling, radiation surveys, personnel dosimetry, bioassay, radionuclide handling, material con-tainment, physical layout, and space requirements for each established i
project.
- b. Evaluate and approve in advance radiation safety procedures and equip-ment for newly conceived projects.
- c. Evaluate and approve, in advance, radiation safety procedure and equipment changes in established projects.
- 3. The Comnittee meets, as necessary, to consider Items 2.b and 2.c above j
and meets approximately quarterly to consider Item 2.a.
The responsi-i bility for scheduling the meeting rests with the Chairperson.
Four 7,Q members constitute a quorum, and approval requires a majority vote of those present.
F orm 20419 PWO
Static ControlSystems 3M TCAAP 590 New Bognton. MN 55112
'~'
85-1.32 QUALITY PLAfi 1 Sep 1981 1
- 4. At least one member of the Isotope Committee reviews and approves copies of purchase requisitions for radioactive material.
If it appears that l
full Committee review is necessary, a meeting is neld to review the i
intended use of radionuclides.
- 5. The Health Physicists on the Committee formally and infornally audit the overall Radiation Safety Program and report to the Committee any observation of noncompliance activities as they pertain to fiRC regula-tions or the 3M Health Physics Manual.
- 6. The Committee reviews and approves proposed amendments and revisions to the Health Physics Manual and USf4RC License 22-00057-06 prior to their i
incorporation.
4.0 VEf4 DOR-PURCHASE ORDER 4.1 Scope This policy applies to the selection of vendors of Type B transport containers.
4.2 Qualified Vendor Selection Materials Control shall select all vendors from the Quality Control Approved Vendor List which is based on:
q 4.2.1 The ability of the vendor to conform to 10 CFR 71, Appendix E.
V 4.2.2 Vendor surveys 4.2.3 Past experience 4.3 P_urchase Order Minimum Requirement-l 4.3.1 This is to include all purchase orders for rental, new equipment, repair or parts.
, 4.3.2 The user supervisor shall review with Quality Control the specification re-quirements.
Ij 4.3.3 All purchase orders will be sent to Quality Control for approval.
I 4.3.4 The Quality Control Supervisor will ensure the purchase order includes:
l l 4.3.4.1 Any special inspection and/or tests required.
l4.3.4.2 Certifications to be furnished.
4.4 Vendor Surveys 4.4.1 Vendor surveys will be performed by the Quality Control group, paying particular attention to the vendor's capability of complying with the j
elements of 10 CFR 71, Appendix E.
j 4.4.2 The Quality control group will present a copy of the New Brighton Plant Vendor '
ttntal to the verdor and use as a guide for survey 4.4.3 'Ibe Quality Control Group will cmplete Vendor Quality System Survey, fonn p
i v
85-21.84 Form 20419 PWO
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New Brighton Plant Plant Manager Manager and RSn
-at --- (1)
Medical Froducts Division j
Static Control Systems Dep't I
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Building 575 Health Physics Nuclear Operations Chelate, Tracers Ebergency Squad Supervisor Superintendent
& Cs-137 Theragr Production Supervisor i
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i i
Building 590 Quality Control Radiation Source Emergency Squad Supervisor Production Supervisor Instant Kit
& I-125 Seed Production Supervisor l
Building 675 Materials Control Static Eliminator Emergency Squad Supervisor Production Supervisor i
k i
Process Technologist 1.
The Plant Manager, Medical Product Division is responsible for carrying out and enforcing the plant safety policies established by the New Brighton Plant Manager.
FIGURE 1 NEW BRIGHTON PIAvr ORGANIZATION CHART August, 1981
)
I
_ Chief Executive Of ficer I
President President International Operations and U.S. Operations Corporate Staf f Services I
Senior Vice President Executive Vice President Administrative Services Electronic & Information Technologies Sector Medical Director Vice President
___ _j Medical Department Electrical Products Group (1) 1 Manager Static Control Systems Isotope Department Committee Ma nager Health Physics Services and Production Manager Corporate Radiation Safety Static Control Systems Of fice r
_ Department (2,3) 3)
Plant Manager & RSO Static Control Systems Manager Department, New Brighton, Ionizing Padiation MN Plant I
Health Physics Supervisor New Brighton Plant Static Control Systems Dept.
4--
(5)
-+
New Brighton, MN Plant Resident Health Physicist 1.
The Isotope Committee informs the Medical Director and the Vice President of the Electrical Products Group of its findings and actions.
2.
The Isotope Committee provides the Static Control Systems Department Plant Manager with the policies and procedures necessary to establish an effective radiation safety program.
3 The Isotope Committee appoints the New Brighton Plant RSO who is responsible to j
the Committee for implementing the radiation safety program.
h.
The Resident Health Physicist is responsible for (1) continuously auditing the New Brighton Plant radiation safety program, (2) for performing a formal quarterly record keeping audit, and (3) informing the Isotope committee of audit i
findings.
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5 The Resident Health Dhysicist, Plant RSO, and Health Physics Supervisor communicate on a daily basis to ensure that an ef fective radiation safety program is being conducted.
FIGUPE 2*
3M MANAGEMENT OPGANI7.ATION CHART August, 1981
Static Control Systems!3M TC AAP 590 Ne.v Brighton. MN 55112 nU 85-1.32 QUALITY PLAN 1 Sep 1981 5.0 INSPECTION 5.1 Scope
[
This section applies to all inspection of Type B containers.
5.2 Responsibility 5.2.1 The Quality Control Supervisor shall be responsible for preparing all in-spection instructions and inspection sheets.
5.2.2 All inspections will be performed by a Quality Control Technician under the direction of the Quality Control Supervisor.
5.2.3 In the event the container is filled by a Quality Control Technician, a second Technician must perform the inspection.
5.3 Receival Inspection 5.3.1 Upon receipt, all containers will be inspected for damage, quality, con-formance and item identification in accordance with specific purchase order requirements and receiving documentation.
5.4 In-Process Inspection 5.4.1 All purchase orders will be reviewed by Quality Control Supervision to de-(^J) t-termine the necessity for special testing and certificate of conformance.
5.5 Final Release Inspection i
5.5.1 Final release inspection will be perforned by a Quality Control Technician under the direction of the Quality Cortrol Supervisor.
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5.6 Disputes I. 5.6.1 Disputes involving quality, between Quality Control personnel and user per-sonnel will be decided by the Plant Manager.
6.0 CONTROL-STORAGE-SHIPMENT f
6.1 Scope l
This section applies to the control, storage and shipment for Type B con-tai ne rs.
6.2 Containers subject to deterioration should be stored in an enclosed storage j
area.
6.3 Upon receipt, all containers shall be directed to Quality Control for in-spection.
6.3.1 Upon completion of inspection, the inspection sheets will be reviewed by Quality Control Supervision and appropriate stickers affixed to the con-tainers.
6.3.1.1 Acceptance - All specifications met
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Hold - Needs repair or further testing, etc.
ss Reject - Cannot be used Form 20419 PWO
Static Control Systems'3M TCAAP 590 New Boghton. MN bb112 85-1.32 QUALITY PLAN 1 Sep 1981 6.4 Ali conditions of the NRC package approval and the U.S. Department of Transportation shipping requirements shall be met.
6.5 All necessary shipping papers will be prepared as required.
Depa rture, arrival time and route will be established and monitored consistent with safe transportation practices.
l l 7.0 CALIBRATION 3
l 7.1 Scope l
l This section applies to all test and survey equipment used for Type B containers.
7.2 Calibration of all test and survey equipment shall be performed in accord-ance with Section 21.0 of the New Brighton Plant Quality Control Manual.
, 8.0 RECORDS i
' 8.1 Scope It is the purpose of this section to describe the manncr in which final documentation is defined, assembled, retained and verified.
I 8.2 Where applicable, records must contain the following:
Cx) l 8.2.1 A description of the type of operation.
8.2.2 Evidence of completing and verified inspection or test operation.
8.2.3 Test Technician signature and date.
8.2.4 Information, related to conditions adverse to quality.
8.2.5 Identification of person reviewing results.
8.2.6 Evioence as to the acceptability of the results.
9.0 AUDITS 9.1 Scope This section applies to all audits to ascertain compliance with tSis manual.
9.2 Internal Audits 9.2.1 Internal audits will be performed by the Health Physics Services Resident Health Physicist on a quarterly basis.
9.2.2 Results of the audit will be reported to the Isotope Committee for action as necessary.
9.3 External Audits 9.3.1 External audits will be held at vendor facilities as necessary and performed i
I under the direction of the Quality Control Supervisor.
l10.0 TRAINING
(]
10.1 Scope This section applies to training of personnel performing activities affecting quality of Type B containers.
Form 20419 PWO
Static Control Systems'3M TCAAP 590 New Br:ghton. MN 55112 O
85-1.32 OUALITY PLAN 1 Sep 1981 10.2 Training sessions will be held periodically to review program requirements for the area of responsibility of the personnel involved.
10.3 Training will be directed toward improved understandi g of the requirements of this manual.
!' 11.0 APPENDICES I
Vendor Quality Manual 85-21.84 - Vendar Quality System Survey t
85-21.85 - Quality Control Specification - DOT 6M-15 Container 85-21.86 - Quality Control Specification - DOT 6M-15 Container 85-21.87 - Quality Control Specification - DOT 6M-15 Container 85-21.88 - Quality Control Specification - Spec 55 - R/A Container Return i
85-21.89 - Quality Control Specification - Spec 55 - R/A Container Preparation
& Release 85-21.90 - Quality Control Specification - R/A Material Container Checkout Procedures 85-21.69, Rev.A - Quality Control Specification - D0T6400 (Super Tiger) &
D0T 6679 (Half-Super Tiger)
Section 21.0 - New Drighton Quality Control Manual 85-11.4, Rev. E - Shipping Checklist
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85-17.50 - Q.C. Container Audit Checklist 85-3.1 - Smear Tes t Standard i
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1 F orm 20419 PWO
FOREWORD (3
\\.)
Gentlemen:
This manual has been prepared for the purpose of assisting any company inte-rested in being a vendor for Static Control Systems, 3M, in the establishment of an acceptable quality assurance system.
Static Control Systems " Vendor Quality Manual" is not intended to dictate to a vendor by rigid terms or statements exactly how a quality control system shall be set up, but rather is intended to provide a background of information which will serve as a guide to indicate a system that will satisfactorily con-trol quali ty.
Static Control Systems is responsible for the quality of all material furnished our customers.
This is alst true of all items we procure which are included in our finished products.
Therefore, it is imperative that sicps be taken to assure that these items are of the required quality.
Static Control Systems has a quality assurance goal of defect free oroducts.
Static Control Systems vendors are encouraged and expected to provide a quality program compatible with this goal.
Only by continuing to produce the best oos-sille products at the best possible price can the Static Control Systems and its' vendors continue to maintain and improve the reputation we now enjoy.
Very truly yours,
$$ $t n M. R. Peters Supervisor, Guality Control l
MRP:pr (2)
1.0 Introduction
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2.0 Quotation and Purchase Order Procedure 3.0 General Quality Requirements 3.1 S.vstem Requirerents 3.2 Vendor Survey and Audit 3.3 Specifications 3.4 First Article Procedure 3.5 Source Inspection 3.6 Vendor Liability 4.0 Quality System Requirements 4.1 General 4.2 Incoming Inspection 4.3 In-Process inspection and/or Tests f'}
4.4 Final Inspection and/or Tests 4.5 Product Verification 5.0 Packaging 6.0 Acceptance Criteria 7.0 Discrepancy Procedure 8.0 Technical Assistance 9.0 Fo rms 1
I O
O
1.0 INTRODUCTION
It is the policy of Static Control Systems to design, develop, and fabri-cate products to the highest standards possible, so that our products shall be delivered to our customers on schedule at a competitive price, and shall meet all specified and implied standards of performance, reliability and quali ty.
The materials from which the products are develooed determine to a large degree the ultimate quality of those products, and the resulting extent of customer good will.
Therefore, reliable vendors are vital to quality production of today's products and for those of the future.
The best interest of Static Control Systems and its vendors are safeguarded when there exists a basic set of specifications which outline the quality responsibilities (.T vendors to Static Control Systems, henceforth referred to as SCS.
This manual defines those specifications and outlines our con-cepts of what we believe to be the responsibilities of a reliable vendor and SCS's system for controlling the quality of finished materials and O
processes.
SCS will welcome any suggestion, which may result in cost savings and/or improved quality.
Such recommendations will receive our special considera-tion.
2.0 QUOTATION AND PURCHASE ORDER PROCEDURE All quote requests will be issued by SCS and, unless exception is exoressed at the time of quotation, the assumption will be made that all product specifications will be fulfilled.
If the vendor cannot meet the specifica-tions as presented in the initial quote request, he must advise SCS in writing when submitting the quotation.
Further, if the specifications are likely, in any way, to cause manufacturing problems or adversely affect the cost or quality of the converted goods, the vendor must advise SCS before submitting the quotation or include an alternate quotation reflecting h's recommendations.
3.0 GENERAL QUALITY REQUIREMENTS Q
3.1 System Requirements SCS is required by contractual obligation to its customers to provide i
an acceptable and complete Quality Control system controlling the acceptance of all materiais and fabrication methods used in the pro-duction of SCS's products.
Since SCS is responsible to its customers for the quality of all products furnished, this responsibility will necessarily extend to all vendors.
Therefore, SCS must take steps to assure that these products are of the required quality.
3.2 Vendor Survey And Audit Prior to issuing production requests with your firm, a survey may be conducted at your plant for the purpose of evaluating the existing quality system.
Upon completion of the survey, you will be informed as to whether you have a quality system acceptable to SCS.
Any de-ficiencies will be brought to your attention. With reasonable advance notice, a SCS Quality Assurance represen:ative may, at any time, ex-amine the materials and/or conduct a quality audit concerning materials being produced or manufactured for SCS.
3.3 Specifications O
SCS drawings are the principal specification for SCS.
These are the ultimate reference for SCS inspection.
Copies of the drawings which i
have been mutually agreed to by SCS and the vendor, in writing, will be supplied by SCS.
No deviations will be accepted without written SCS approval.
l 1
SCS will provide color chips, visual standards and other standard workmanship requirements not shown on the drawing.
SCS will interpret terminology for workmanship techniques, which have been mutually agreed to.
3.4 First Article Inspection First article inspection is to assure that the first shipment offered to SCS meets all quality requirements.
First article inspection may be required whenever revisions are made to existing manufacturing tools, processes or specifications.
The vendor should submit samples only after he has conducted an inspec-O tien of the sempies end nes meee eny necessery corrections to en out of standard condition.
These samples must reflect the design intent, color and shape as outlined in the drawings and specifications.
l
O Discrepancies detected in the first article by SCS may be cause for correction and submission of new samples by the vendor.
3.5 Source Inspection SCS customer source inspection is a condition of the purchase order.
It is the prerogative of a SCS customer to inspect any item supplied to that customer.
However, this inspection does not guarantee final acceptance whether by SCS or ultimately by the customer.
Rather, this is only a surveillance for the purpose of detennining that program standard requirements are being observed.
3.6 Vendor Liability The vendor will be liable and shall remain responsible for raw materials, semi-processed, or finished product meeting t'he SCS soecifications throughout the receiving, storage and converting process.
Damage to these materials attributable to the acts or omissions of SCS, its employees, or agents, are excluded.
O 4.0 ount11v SvSTen asculassenTS 4.1 General The vendor shall provide a system to control materials produced within his shop. This system shall provide assurance that the material meets physical, visual, functional and dimensional requirements.
The control system shall include the following:
A.
Receiving Inspection B.
Verification of Production Process.
C.
Outgoing Inspection j
D.
Necessary Documentation To Suoport The Above.
4.2 Incoming Inspection The vendor shall provide a system to inspect and control all incoming ma terial.
Inspection for meeting specification requirements and con-dition must be perfomed.
Control must be maintained to assure material not meeting requirements is not introduced into products for SCS.
Ma te-O ria1 suoP14ed by scs is to be used onix in convertia9 scs oroducts-
O 4.3 Ir-Process Inspections and/or Tests A system shall be in effect for inspecting or testing material or product during processing.
The system shall provide assurance that the material or product continues to meet the visual and dimensional requi remen ts. All material or product processed during and after a machine set up and/or tool change shall be inspected or tested for the characteristics controlled or affected by the coeration until there is assurance that the material or product consistently meets speci fications.
Reworked material or oroduct shall be reinsoected and/or retested to assure conformance with soecifications.
4.4 Final In!,pections and/or Tests The vendor is to have a system to assure that material or oroduct meets the visual and dimensional requirements prior to shipment.
The vendor is responsible for the inspection of all parts oroduced in his shop.
The vendor must separate and identify all out of stan-dard material from acceptable stock prior to shipment.
In some in-()
stances, a particular in-process inspection and/or test may be recog-nized as part of the final inspection.
4.5 Product Verification It may be detemined that the best interest of SCS will be served by requiring verification of product quality in a vendor's plant. Such verification will be conducted by a SCS Quality Assurance represent-ative or team and may consist of reviewing objective evidence of con-formance and/or witnessing of measurements or tests perfomed. Al-though verification of the product is perfomed at the vendor's plant, final inspection and acceptance may take place upon receipt by SCS.
The vendor may be required to submit an inspection report upon product delivery.
5.0 PACKAGING Iri the absence of packaging irstructions, the packaging must maintain the integrity of the material during shipping as well as during nomal storage and handling.
Shipments may be rejected upon receipt for improper packaging or identification.
l l
Shipments, under all circumstances, must be protected from effects of contamination to insure receipt of materials in good condition.
6.0 SCS ACCEPTANCE CRITERIA Contracted material is normally inspected by random samoling.
Acceptance or rejection is based upon the findings in the samole.
It is SCS's practice to use first article sampling methods (see Section 3.4).
Quality levels may be assigned to various characteristics at this time.
Material is inspected following single and sequential sampling plans based on tiil-Std 105D.
7.0 DISCREPANCY PROCEDURE In the event that discrepant material should be fcund during incoming in-3 spection or testing, a Discrepancy Report will be prepared.
SCS reserves the right to reject and return to the vendor for full credit any material determined to be defective.
Shipments found to be defective by SCS will be returned to the vendor, ac-companied by a Discrepancy Reoort (see attachment).
SCS shall not be obligated to subject a rejected shipment to 100% inspection of all characteristics.
Inspection may stop on a shipment at any time dur-ing inspection or test upon determining that the lot is unsatisfactory.
SCS inspection is by an approved samoling plan basis.
It is the vendor's responsibility on rejected shipment to notify SCS of cor-rective action taken when requested.
The vendor is to notify the aporopriate SCS personnel with details.
8.0 TECHNICAL ASSISTANCE 8.1 Assistance to vendors in producing material to our requirements improves the quality of finished goods received, aids in meeting production re-quirements, and reduces the cost of audit / testing by SCS.
To accomplish this, SCS technical personnel contact and work with the vendors to solve quali,ty problems and to help control quality at the vendors' plants.
8.2 SCS technical personnel are available to discuss the coordination of O
requirements w4th tne vendors in oreer to neip the veneer proeuce ec-
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ceptable quality material or to review inspection / test methods and to correlate inspection / test procedures.
The confinnation and docu-mentation of acceptable process oractices (follow recomended pro-cedures) is required of the vendor prior to technical assistance.
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1 DISPOSITION O Use as is O Return to vendor - 3M expense O Rework by 3M O Return to vendor - vendor expense Quantity returned S.C.S. Rrmarks inspected By Date Part Disposition Authorized By:
Vendor Note - This section of the pink copy must be completed and returned with the corrected materiel.
Corrective Action O Reworked O Remade Fxplanation f
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Date Vendor Segnature White G reen Canary Pink Goldenrod Quahty Control Materials Control Vendor Vendor Production 85-1.24 3E Action ~2coraper
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Date Received Quantity DISCREPANCY DATA Item Requiremern Inspection Results
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DISPOSITION O Use as is O Return to vendor - 3M expense O Rework by 3M O Return to vendor - vendor expense Quantity returned S.C.S. Remarks inspected By Da te Part Deposition Authorized By:
Vendor Note - This section of the pink copy must be completed and returned with the corrected material.
Corrective Action O Reworked O Hemade planation Vendor S.gnature Date White G reen Canary Pink Goldenrod Quanty Conteci Materials Control Vendor V endor Production 85-1.24 3@ action zooraper
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Date Received Q uan tity DISCREPANCY DATA I
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Vendor Note - This section of the pink copy must be completed and retu.ned with the corrected material.
Corr:ctive Action O Reworked O Remade xplanation Vendor Signature Date White G reen Canary Pin k Goldenrod Quality Conteci Materials Control Vendor V endor Production 85-1.24 3M Action 200 Paper
Form 16519-PWO g
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static contros sustems G-nn, DISCREPANCY REPORT Report No..L 0 0 I Pr o.
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Date Receivert Quantity DISCREPANCY DATA It:m Requirement inspection Results
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DISPOSITION O Use as is O Return to vendor - 3M expense O Rework by 3M O Return to vendor - vendor expense Quantity returned S.C.S. Remarks i
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i I Vendor Note - This section of the pink copy must be completed and returned with the corrected material.
l Corrective Action O Reworked O Remade F planation i
Vendor Signature oate j.
White G reen Canary Pink Goldenrod Ovality Control Materials Control Vendor V endor Production l 85-1.24 E 1wtionaooroper
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l Vendor Note - This section of the pink copy must be complete ' and returned with the corrected material.
' Corrective Action O Reworked O Remarle planation Vendor Signature Date White Green Canary Pink Goldenrod Quilf ty Control Materials Control Vendor Vendor Production 85-1.24 3 bon roa s' aper
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85-21.84 1 F b 1981 g s.
VENDOR QUALITY SYSTEM SURVEY V
VENDOR SURVEYED
- /
PERFORMED BY-DATE i
A.
MANurACTURING PROCEDURES Work Instructions Sequence Of Operations Inspection Points Latest Revision In Use RM or Component Identification Ccmments B.
PROCEDURE CONTROLS
(~3 Q.C. Manual
s /
Written Quality Procedures Written Test / Inspection Instructions Workmanship Standards Comments C.
QUALITY ORGANIZATION PERSONNEL Manager Supervisor Engineers Technicians Commen ts f')
s-
85-21.84 1 Feb 1981 i
Vendor Quality System Survey 1 1
D.
DRAWING Afl0 CHANGE CONTROL Approval Change Approval Change Notification Comments E.
INCOMING IflSPECTION Receival Control Hold Area Inspection Instructions Defined Requirements Sa:^1e Plans Reject Material Control Comments i
C:)
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F.
Ift-PROCESS INSPECTION Instructions First Article Inspection Rejected Material Handling Inspection Records l
Reinspection Repair / Rework Q.C. Authority l
Comments i
G.
Fif1AL IflSPECTION Instructions i
Sampling Plan Accept / Reject Criteria Reject flaterial Handling Inspection Records - Available To 3M Reinspection Repair / Rework
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Authority To Release Material i
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L5-21.84 1 Feb 1981
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Vender Quality System Survey G.
FINAL INSPECTION Comments H.
PACKAGING / SHIPPING INSPECTION Instructio-Sampling P.
Rejected Material Handling Control Of Final Accept / Ship Commen ts
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I.
STOCK CONTROL Identification Of Material Facilities And Space Comments
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INSTRUMENT CALIBRATION AND REPAIR Ins truc ti ons Schedules Records NBS Traceable Control Of Primary Standards Comments,
K.
RECOMMENDATIONS (vO 1
85-21.84 1 Feb 1981 m
Vendor Quality System Survey U K.
RECOMf1ENDATIONS, Quality Engineer Date
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Static Control Systems *3M TC A AP $90 New Brighton MN 55112 Quality Control Specification gg)
DOT 6M-15 GALLON SIZE W/5" 2R CONTAINER (ACCEPTANCE TEST) i 1.0 WORKMANSHIP Drum Inspection Level 100%
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Equipment:
None l
Method:
Visual Requirement:
Drum must be free of dents, scratches, and rust and all welds must be secure.
Drum must have four (4) vent holes with caplugs in them.
Drum must be embossed on bottom with certification DOT 17C STC.
Vendor must supply certification containing drum speci-fications such as gauge, material, color, etc. and comply with NRC Regulations for Container QA Appendix E to 10 CFR Part 71 and to 3M Company P.O.
2.0 WORKMANSHIP 2R Inner Container Inspection Level 100%
Equipment:
None Method:
Visual i
j Requi rement:
Cap of container must screw on and off easily.
2R container must fit snugly within insulation.
Container must be labeled by stamp-ing " Radioactive Material".
The container will have Cerficiation p
of Confonnance to NRC Regulations for Container QA Appendix E to 0
CFR 10 Part 71 and to 3M Company P.O.
3.0 WORKMANSHIP Insulation Inspection Level 100%
4 Equipment:
None Method:
Visual I
Requi rement:
Top section must contain finger holes.
Second section must con-tain 2 rings placed at same functional point as finger holes.
Certification required of insulation in compliance with NRC Re-gulations for Container QA Appendix E to 10 CFR Part 71 and to 3M Company P.O.
4.0 WORKMANSHIP Labeling Inspection Level 100%
Equipment:
None Method:
Visual Requirement:
Label screws or welds must be well attached.
Label must be marked as follows:
Radioactive Material DOT - 6M Type B 18 i (Year of Certification) 3M Company, New Brighton, MN 55112.
Label will be in conformance with NRC Regulations for Container QA Appendix E to 10 CFR Part 71 and to 3M Company P.Q.
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Quality Control Specification 25 Sep 1981 DOT 6M-15 GALLON SIZE W/5" 2R CONTAINER (ACCEPTANCE TEST) 5.0 CERTIFICATION Equipment:
None Method:
Visual Requirement:
DOT 6M-15 Gallon Containers w/5" 2R must have Cerfitication of Complaince with Applicable DOT Specifications on NRC Regulations for Container QA Appendix E to 10 CFR Part 71 and 3M Company P.O.
Certification to be supplied by vendor.
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Ouality Control Specification gg) l DDT 6M-15 GALLON SIZE W/5" 2R CONTAINER (PREPARATION AND RELEASE) l 1.0 WIPE TEST Polonium Nitrate Container Equipment-Nuclear Chicago Model 1042 or equivalent counting system Method:
Test Standard 85-3.1 Requi rement:
Test Standard 85-3.1 2.0 PACKAGING 2R Inner Container Material:
Vermiculite Method:
Manual Requi rement:
Open Polonium Nitrate container and place inner package in 2R inner container and pack completely with vermiculite.
Close 2R inner container.
3.0 WIPE TEST 2R Inner Container Equipment:
Nuclear Chicago Model 1042 or equivalent counting system Method:
Test Standard 85-3.1 Requi rement: Test Standard 85-3.1 Il 4.0 LABELING 2R Inner Container l
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Material:
Brady Radiation Label RC-538 l
Method:
Manual Requi nnent:
Label to be placed on top of cap of 2R inner container.
Record bead group's mci quantity and bead group's date of assay on label.
5.0 CLOSURE DOT 6M-15 Gallon Size W/5" 2R Container Equipment:
Two (2) crescent wrenches Method:
Manual Requirement:
Put 2R inner container in drum and secure.
6.0 RELEASE DOT 6M-15 Gallon W/5" 2R Container Equipment:
Eberl'ine Model R0-2 Survey Meter Nuclear Chicago Model 1042 or equivalent counting system.
Method:
Test Standard 85-3.1 Quality Control Manual 11.01, Section 3.70-3.90 Requi rement:
Test Standard 85-3.1 Use Brady Radiation Label RC-538 and either Quality Control release label 34-7005-3480-2 or 34-7014-1077-0.
Quality Control Manual 11.01, Section 3.70-3.90
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J.A. Sjolander M.R. Peters of 2 Form 202;6 PWO
l static control systems 3M TC A AP 590 New Brighton. MN 55112 O'
8 ouality control specification 981 DOT 6M-15 GALLON SIZE W/5" 2R CONTAINER (PREPARATION AND RELEASE) l 7.0 CERTIFICATION Equipment:
None Method:
Visual Requi rement:
Certification of Contents to be supplied by Quality Control to l
customer with information supplied by Bead Production.
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-s Quality Control Specification 85-21.87 25 Sep 1981 DOT 6M-15 GALLON W/5" R-2 CONTAINER RETur; 1.0 ACCEPTANCE Equipment:
Nuclear Chicago Model 1042 or equivalent counting system Health Physics Log Eberline R0-2 Survey Meter Release Label 34-7005-3480-2 Method:
Test Standard 85-3.1 Survey inside of container with R0-2.
Place Release Label on container.
Requi rement: All testing done by Health Physics Survey limits = background
_4 Test Standard 85-3.1 (: x 10 pCi)
Results recorded in Health Physics Log (O
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Quality Control Specification gg)
SPEC FICATION 55 - RADI0 ACTIVE MATERIAL CONTAINER RETURN l 1.0 ACCEPTANCE I
Equipment!
Nuclear Chicago Model 1042 or equivalent counting system l
Eberline R0-2 Survey Meter Health Physics Log Release Label 34-7014-1077-0 Method:
Test Standard 85-3.1 Survey inside of container with R0-2.
Place Release Label on container.
Requirement: All testing done by Health Physics Survey limits = background Test Standard 85-3.1 Results recorded in Health Physics Log
' 2.0 IDENTIFICATION Equipment:
None Method:
Visual Requirement:
Container identification will be in accordance with receiving
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documents.
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3.0 PHYSICAL CONDITION Equipment:
None Method:
Visual Requirement:
Container will be free of critical damage.
1 7
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Static Control Systems!3M TC A AP 590 New Brighton. MN 55112 Quality Control Specification DOT SPECIFICATION 55 - RA]I0 ACTIVE MATERIAL CONTAINER PREPARATION AND RELEASE 1.0 WORKMANSHIP Equipment:
None Method:
Visual l
Requi rements:
Container free of cracks, broken welds, or critical damage.
I 2.0 CLOSURE I
Equipment:
Wrenches Method:
Manual Requi rements:
Tighten container securely 3.0 WIPE TEST AND SURVEY Equipment:
Eberline R0-2 Survey Meter Nuclear Chicago 1042 or equivalent counting system Method:
Quality Control Manual 11.01 Section 3.70-3.81 Test Standard 85-3.1 Requi rements:
Quality Control Manual 11.01 Section 3.70-3.81
(~'3 Test Standard 85-3.1
^
4.0 LABELING Equipment:
Brady Radiation Label RC-538 Release Label 34-7014-1077-0 Method:
Complete labels and place on container Requirements:
Both labels have correct information and are placed on container.
5.0 RECORD Equipment:
Quality Control Daily Wipe Log Method:
Record sarvey and wipe test results Requirements:
Data recorded in Quality Control Daily Wipe Log 6.0 RELEASE Equipment:
Eberline R0-2 Survey Meter Method:
Quality Control Specification 85-21.-90 Requirements:
Quality Control Specification 85-21.90
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Date Approved by Date Prepare v
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Static Control Systems'3M TC A A P 590 New Brighton. MN 55112
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RADI0 ACTIVE MATERIAL CONTAINER CHECK 0UT PROCEDURES 1.0 CLOSURE Equipment:
None Method:
Visual Requirements:
Bolts in place and secure.
Container will have two (2) seals 2.0 SURVEY Equipment:
Eberline R0-2 Survey Meter Method:
Survey surface of container Requi rements:
<200 mr/hr at surface arx1 < 10 mr/hr at 1 meter 3.0 COUNT Equipment:
None Method:
Visual Requirements:
S/B ticket corresponds to amount 4.0 CURIE COUNT C' )
Equipment:
None Method:
Visual Requirements:
Correct curie content indicated on label and S/B ticket 5.0 SHIPPING CHECKLIST Equipment:
None Method:
Visual Requirements:
Production records contain complete shipping checklist 84-11.4 6.0 PACKING SLIP Equipment:
None Method:
Visual Requi rements:
Order contains complete packing slip 7.0 VERIFICATION Equipment:
None
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Method:
Visual Requi rements: Quantities on certifications, checklist, and S/B ticket must correspond.
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.A. Sjolander M.R. Peters Fo m 20226 PWO
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Ouality Control Specification 2
81 RADI0 ACTIVE MATERIAL CONTAINER CHECK 0UT PROCEDURES 8.0 CHECKLIST Equipment:
Quality Control Container Audit Checklist 85-17.50 Method:
Manual Requi rerents:
Checklist complete and placed in Production folder O'
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Static Control Systems'3M TCAAP 590 New Brighton, MN 55112 i
V Quality Control Specification 85-21.69, Rev. A 00T 6400 (SUPER TIGEP,) & D0T 6679 (HALF-SUPER TIGER) 20 Aug 1981 1.0 INTERIOR CONDITION Method:
Visual Requi rement :
No large dents or holes in interior walls that would result in loss of integrity.
j 2.0 INNER GASKET CONDITION Method:
Visual Requi rement:
No loose, torn or weatherbeaten gaskets (weathering indicated by hairline cracks or brittleness).
3.0 INNER DOOR HINGES Method:
Visual Requi remen ts:
No cracks in hinge to body weld.
Hinge must be l
lub ri cated.
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Visual I
Requi renent:
Door must swing freely in opening and closing.
All bolt holes must be in alignment when door is closed.
I Door must seal properly when closed.
(No warpage).
5.0 INNER DOOR BOLT H0LES ththod:
Vis ual Requi rement :
Bolt holes, must be clean and not cross-threaded.
Note: The threaded holes and bolts are the means by which the primary seal is established.
Any damage must be repaired to insure propor operation.
6.0 INNER D0OR BOLTS Method:
Visual 4
Requi rement:
Inner door bolts must be inspected for thread damage each time the door is opened, Damaged bolts must be replaced irmediately with approved replacemcnt bolts.
7.0 FREON INLET CONNECTION Method:
Remove the protective cap screw and depress the plunger.
Check inlet connection for damage.
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Static Control Systemsf3M TCAAP 590 New Brighton, MN' 55112
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Quality Control Specification 85-21.69, Rev.A D0T 6400 (SUPER TIGER) & DOT 6679 (HALF-SbPER TIGER) 20 Aug 1981 7.0 FREON INLET CONNECTION (Con't.)
Requi remen t:
The plunger must be operable.
There must be no ohysical damage to the inlet connection.
If the connection appears canaged or is unworkab'e re-t place the connection.
After any repair < replace-nent of the connection a test must be made with the freon test kit.
i 8.0 OUTER GASKET CONDITION i
Method:
Visual Requi rement:
See 2.0 9.0 OUTER D0OR HINGES Method:
'li s ual Requi remn t:
No cracks in hinge to body weld.
Hinge must have workable Zire fitting and must be lubricated.
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10.0 OUTER D0OR BOLT H0LES Method:
Visual I
Requi rement:
No dirt or rust in threads. Threads must be undamaged. l Damaged threads must be repaired or replaced as l
necess a ry.
11.0 OUTER DOOR ALIGNMENT Method:
Visual 1
1 Req ui rement:
See 4.0 l
12.0 OUTER DOOR BOLTS Method:
Visual Requi mmen t:
Bolts must have no cracks, damaged threads or excessive rust.
Bolts must be cleaned and lubricated each time unit is used.
Replacement bolts must meet certifi-cation mquirements of 10 CRF 71.12, DOT 6400 and D0T 6679.
13.0 EXTERIOR CONDITION l
"ethod:
Visual
(
Requi rement :
No damage which may affect unit's integrity.
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,.,O Ouality Control Specification 85-21.69, Rev.A DOT 6400 (SUPER TIGER) & D0T 6679 (HALF-SUPER TIGER) 20 Aug 1981 14.0 HOLD DOWN DEVICES Method:
Visual Requi rement:
No defective hold dcons on trailer.
Slots in container must not be warped or show signs of f ailure.
Note:
Defective hold downs or slots must be repaired immedi-ately.
15.0 NAMEPLATE Method:
Visual Requi rement:
Nameplate must be in place on container.
The name-plate can have no loose or weak fasteners.
16.0 HALOGEN LEAK TEST Equi pment:
Leak Test Kit (Supplied with unit)
Method:
Close and bolt the aluminum inner door torquing the bolts hand tight using a standard length wrench.
f)
(Never use pneumatic tools or cheater bars).
Introdua freon into the body cavity by connecting a can of Freon 12 to the check valve in the center of the aluminum door.
(Use hose supplied for this purpose).
Puncture the can with the needle valve and allow the Freon to enter the Super Tiger cavity.
Allow the Freon to reach equi lib ri um.
Slowly move the electronic halogen de-tector around the edge of the aluminum door.
A signal from the detector above background indicates a leak.
If a leak is indicatec: tighten bolts slightly.
If the leak persists the gasket most be reinspected for integ-ri ty.
Requi rement:
The closure must be completely leak tight.
Shipment cannot be approved until the leak test is passed.
17.0 AUTHORIZATION FOR RELEASE Method:
As each inspection item is completed it must be checked off as accepted or rejected on the appropriate checklist.
Requirement:
Coctainer is released for use when all inspected items are completed and in compliance.
g Date Prepared By Date l Approved By 7M/
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Static Control Systems /3M TCAAP 590 New Brichton, MN' 55112
'6 i%J Quality Control Specification 85-21.69, Rev.A DOT 6400 (SUPER TIGER) & D0T 6679 (HALF-SUPER TIGER) 20 Aug 1981 P reload Postload Acc.
Rej.
Acc.
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1.0 Interior Condition 2.0 Inner Gasket Condition 3.0 Inner Door Hinges 4.0 Inner Door Alignment 5.0 Inner Door Bolt Holes 6.0 Inner Door Bolts 7.0 Freon Inlet Condition 8.0 Outer Gasket Condition 9.0 Outer Door Hinges 10.0 Outer Door Bolt Holes i
O ii.0 Outer Door A,4 nment 9
12.0 Outer Door Bolts 13.0 Exterior Condition 14.0 Hold Down Devices 15.0 Nameplate 16.0 Halogen Leak Test Inspector Date Approval Date
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TCAAP 590. NEW BRIGHTON. MINNESOTA 55112 QUALITY CONTROL MANUAL CALIBRATION 21.0 21.10 GENERAL POLICY The intent of this procedure is to orovide for periodic in-spection of gauges and gauging equiprent on a frequency which will assure detection of gauge wear before tne wear is out of gauge tolerance.
The requirements of MIL-C-45662A will be adhered to in the New Brighton plant.
21.20 CALIBRATION POLICY
.21 Master Gauge Calibration - All gauges or standards used to calibra te working gauges or standards in the departmert will be directly traceable to N.B.S.
Standarde The certificates of calibration received will be kept by quality engineering.
.22 Minimum Calibration - This procedure provides only the r~g minimum periodic inspection of gauges necessary to detect
(/
normal wear characteristics.
The individual in possession of the gauge shall be responsible for the condition of this gauge and he shall make the necessary basic checks to assure that his gauge is in good working condition and has not been damaged.
This will best be accomplished by checking the calibration of an instrument, whenever possible prior to use.
.23 Calibration Frequency Policy - Unless otherwise requested by the cognizant engineer, the following recalibration fre-i quencies shall be maintained:
l l
.23.1 One month recalibration frequency:
Counter-Scalers
.23.2 Three months recalibration frequency:
Micrometers and micrometer-equipped gauges Dial indicators and dial indicator-equipped gauges 23.3 Six months recalibration frequency:
Electrical test instruments
- Electrical gauging equipment
- Vernier calipers and Vernier-equipped gauges rm
- Test equipment (spring, hardness, torque)
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- High magnification comparators (air gauges, reed type)
- Masters - gauge blocks, optical fl ats, cylindrical squares l
Continued FORM I S 0 8 0- A +wo
om Static Control Systems Qcomin
, O-TCAAP 590. NEW BRIGHTON, MINNESOTA 55112 QUALITY CONTROL MANUAL CALIBRATION 21.0
.23.4 Twelve months recalibration frequency:
- I n s e r t i o n-ty.;e gauges (plug, thread gear wi res)
- Surface plates
- Reference gauges (parallels, angle plates, V-blocks)
- Hand gauges (feelers, radius, scales, tapes)
- Optical gauging equipment
- Special 3M designed mechanical gauging equipment
.24 Sealed Gauge Calibraticn Policy Infrequently used gauges shall be sealed in an appropriate container and the seal shall be stamped with the gauge inspector's stamp.
Any gauge which has an intact seal, at the next scheduled l
recalibration period shall not be calibrated.
l ()
Sealed gauges shall be identified with the effective cali-l bration sticker regardless if the gauge was actually re-l calibrated or not.
.25 Calibration Frequency Switching Terms:
- Normal
= Per Section 21.23
- Tightened = One calibration interval shorter
- Reduced
= One calibration interval longer Normal To Tightened:
- Adjustmants required on two consecutive normal recali-brations.
Normal to Reduced:
- No adjustments required on three consecutive normal re-calibrations.
Reduced To Normal:
- An adjustment required while at the reduced interval.
',(])
Tightened To Normal:
- No adiustments required on three consecutive recalibrations while at the tightened interval.
Continued FORM t 3 0 0 0- A+WO
Um Static Cintro15ystems mAomeu TCAAP 590. NEW BRIGHTON. MINNESOTA 55112 QUALITY CONTROL MANUAL CALIBRATION 21.0
.26 Calibration Adjustments Any calibration adjustments that are required shall be made only by the designated calibration technician or such other technicians as shall be designated by the Quality Supervisor.
.27 When any instrument is found to be out of calibration all personnel using the instrument shall be informed so that any required corrective action on affected parts may be taken.
.28 Any e't of calibration instrument found to be unrepairable she e discarded and its inspection record so noted.
The serial number may then be reissued.
21.30 RECORDS
.31 Each 3M owned gauge and standard will be assigned an in-dividual number.
()
.32 Each 3M gauge or standard shall have its number permanently etched or engraved in a prominent, non-critical area.
.33 Repairs, other than minor cleaning, on a 3M gauge, shall be recorded on the back of the calibration record card.
.34 Quality Engineering shall be responsible for maintaining the calibration records for the working gauges and standards.
21.40 CALIBRATION VERIFICATION
.41 A system of dated calibration s tickers will be provided ' o t
ve ri fy the calibration when completed.
.42 The inspector will use only equipment that is in calibra-tion per the calibration s ticker.
.43 The gauge inspector is responsible for stamping the sticker with the date the gauge was calibrated and accepted.
.44 The gauge inspector shall 1ffix the dated s ticker di rectly onto a non-cri ti cal s urf ace of the gauge.
If the gauge is always s tored in i ts own case, it is acceptable to affix the s ticker to the case prosiding the case is also iden-ti fied with the gauge number.
- ()
Continued
~
FORM t 3 0 80- A+wo
um Static Control Systems mJmmon TCAAP 590. NEW BRIGHTON, MINNESOT A 55112 QUALITY CONTROL MANUAL C ALI B R AT ION 21.0 21.50 CONTROL OF GAUGE PURCHASED Quality Engineering shall be responsible for the final app rn val of all gauges or standards purchased.
The basis for selecting a speci fic gauge will be as follows:
.51 Is the gauge capable of measuring to one-tenth of the total tolerance of the part to be meas ured ?
.52 Is t r. _ gauge durable and not s ubject to operator feel ?
.53 Is the gauge traceable to the Bureau of Standards and can it be recalibrated ?
.54 Is the gauge the bes t gauge for the application ?
.55 Purchasing shall be responsible for assuring that the signature appears on all inspection department gauge purchases.
.)
.56 The selection of gauges for the production groups shall be the responsibili ty of the Production Engineer.
Q ual i ty Engineering shall act in an advisory capaci ty in as s i s ti n g in the selection of gauges.
21.60 MAINTENANCE RESPONSIBILITY
.61 Quality Engineering and the respective Production Engineers are jointly responsible for assuring tha t the gauges in the j
respective departments are being maintained in accordance wi th the provision of this manual.
t l
.62 Quality Engineering shall periodi cally conduct "sys tem l
audits" of the program to determine the degree of conform-l ance to this procedure.
I 21.70 AUTHORITY The authority for the contents of the calibration p ro ce du re s are:
i l
. 71 MI L S TD-120, Gauge Inspection
.72 Commercial Standards Booklet CS (E) 119-145 (Published by the Department of Commerce) Dial Indicator Gauges I
.73 Screw Th read S tanda rds For Federal Service - Handbook H-28 l
December 1977 l
\\
i 85-11.4, Rev. E ro m m -crwo 1 Jan 1978 SHIPPING DEPARTMENT CHECK LIST 1 ]
ND-DATE PLANT ORDER NUMBER KM-I ITEM CARRIER B/L NO.
mci ISOTOPE mci ISOTOPE mci ISOTOPE mci ISOTOPE mci ISOTOPE CONTAINERS (How Many):
PAPERS:
O Returnable - Number inside Outside O Non-Returnable - Number O
DTPA Insert O
O i Mold O Taped O Labeled S
D ig Foam O
Dear Doctor O
O Can O Labeled O Sealed O Insert O
O SHIPPER'S CERTIFICATION O LABELS:
SEALS:
O Address O Danger-Peligro O-O White 1 0 Empty O Carton Stapled O Yellow II O
O Banded O Yellow lli O
O Container Sealed Container Wipe Net CPM Container Wipe
__ Net CPM Surface MR/ Hour Surface MR/ Hour At 36 inches _
MR/ Hour At 36 Inches MR/ Hour By
/
Lbs.
By
/
Lbs.
Container Wipe Net CPM Container Wipe Net CPM Surface MR/ Hour Surface MR/ Hour At 36 inches MR/ Hour At 36 Inches MR/ Hour By
/
Lbs.
By
/
Lbs.
l I
Container Wipe Net CPM Container Wipe Net CPM Surface MR/ Hour Surfaca MR/ Hour At 36 Inches MR/ Hour At 36 inches MR/ Hour By
/
Lbs.
By
/
Lbs.
Container Wipe Net CPM Container Wipe Net CPM Surface MR/ Hour Surface MR/ Hour At 36 loches MR/ Hour At 36 Inches MR/ Hour By
/
Lbs.
By
/
Lbs.
Container Wipe Net CPM Container Wipe Net CPM A
Surface MR/ Hour Surface MR/ Hour V
At 36 inches MR/ Hour At 36 Inches MR/ Hour By
/
Lbs.
By
/
Lbs.
l
_ _ -. _. _ _ _ _ _ _ _ _ _ _ _ _. _ ~.. _... -, _. _ _ _ _ _. _ _,. _.. _ _.
.. _. _. ~ _ _, _. _ _
.y reau em.c ewo 85-11.4, Rev. E 1 Jan 1978 SHIPPING DEPARTMENT CHECK LIST ND-DATE PLANT ORDER NUMBER KM-ITEM CARRIER B/L NO.
mci ISOTOPE mci __
ISOTOPE mci ISOTOPE mci
_ ISOTOPE mci ISOTOPE CONTAINERS (How Many):
PAPERS:
O Returnable - Number Inside Outside P
't O Non-Returnable - Number DT Insert 0
t ca "
ig Mold --.
O Taped O Labeled g
D a ing Foam O
Dear Doctor O
O Can O Labeled O Sealed O Insert O
O SH ER'S CERECAE O LABELS:
SEALS:
O Address O Danger-Peligro
)
O White i O Empty 0 Carton Stapled O Yellow 11 O
O Banded O Yellow Ill O
O Container Sealed Container Wipe Net CPM Container Wipe Net CPM Surface MR/ Hour Surface MR/ Hour At 36 inches MR/ Hour At 36 Inches MR/ Hour By
/
_ Lbs.
By
/
Lbs.
Container Wipe Net CPM Container Wipe Net CPM Surface MR/Hous Surface MR/ Hour At 36 inches MR/ Hour At 36 Inches MR/ Hour By
/
Lbs.
By
/
Lbs.
)
Container ' lop Net CPM Container Wipe Net CPM Surface MR/ Hour Surface MR/ Hour At 36 Inches MR/ Hour At 36 Inches MR/ Hour By
/
Lbs.
By
/
Lbs.
Container Wipe Net CPM Container Wipe Net CPM Surface MR/ Hour Surface MR/ Hour At 36 inches MR/ Hour At 36 Inches MR/ Hour By
/
Lbs.
By
/
Lbs.
i Container Wipe Net CPM Container Wipe Net CPM l p Surface MR/ Hour Surface MR/ Hour V
At 36 inches MR/ Hour At 36 Inches MR/ Hour By
/
Lbs.
By
/
Lbs.
1 L..
f 85-17.50 25 Srp 1981 QUALITY CONTROL CONTAINER AUDIT CHECKLIST O
- Bolts in place and secure CLOSURE 4
SEALS
- Container has two seals SURVEY
<200 mr/hr at surface COUNT
- S/B ticket corresponds to amount CURIE COUNT
- Correct curie amount on label and on S/B ticket.
O SHIPPING CHECKLIST
- Order contains Shipping Checklist PACKING SLIP
- Order contains Packing Slip VERIFICATION
- Quantities on Certs, Checklist and S/B ticket correspond.
Technician Date O
Static Control Systems 3M TCAAP 590
,, New Brighton MN 55112 b
85-3.1, Rev.A STATIC CONTROL SYSTEMS TEST STANDARD 22 Auo 1981 TEST:
Smear Test Page 1 of 2 SCOPE This standard covers the equipment and procedures used in determining the amount of removable activity on an area.
PURPOSE OF TEST The radioactive contamination or leakage on a particular radioactive device or area can be of two types:
external contamination from the surroundings, or contamination caused by leakage from the source.
The initial smear carried out on all devices will detect either type.
The seven day smear test is designed to pick up the second, or leakage, type of contamination.
That is, a sample which is clean in the initial smear and shows a positive seven day smear can be suspected of leaking.
METHOD The smear test is carried out by wiping all available surfaces of the device with a small (one inch cube) sponge or a one inch diameter filter paper disc moistened with distilled water.
The sponge or disc is then placed in a device which will respond to the presence of radioactivity and the radioactivity determined.
O Care must be taken to see that the most critical area 3 are smeared adequately. Thcse include the areas of seals or welds on all radiation sources and all joints or seals on self-luminous devices.
In most cases (beta or gamma emitters) the radioactivity of the smears is determined with an Eberline Model HP-190 detector having a 1.4 to 2.0 mg/cm2 window.
The de-tector ie mounted in a lead shield to reduce background.
The sample is mounted on an aluminum ?an, positioned under the detector with an aluminum slot system and the counts are recorded by means of an Eberline Model MS-3 or equivalent scaler.
The counting ef 'iciency of such a device, which must be monitored by use of a suitable standarc, is 15-40%, depending on isotope.
In the case of alpha sources. ' Baird Dual Channel Automatic Planchet Counter or equivalent ficw gas counter ing proportional gas, should be used to monitor the alpha activity.
The efficiency for this system is from 25-40%.
Correction for t ackground counting rate must be made and sufficient counting time allowed to reduce inaccuracy due to statistics to an acceptable value. This is especially important in the case of final smear tests made by 0.C. as a part of acceptance testirig.
Proper operation af the counter-scaler should be checked at least daily by use of the working standa -d provided for each unit and the count rate must fall within the limits given on the container.
If the count rate is out cf specification, recali-brate per Article 21.10.
pG Prepared By:
Production Quali ty Plant s
Su rvisi Superv ion Manag ment
. f fb
' ' - ^
Static ControlSystems 3M TCAAP 590 0
ew Brighton. MN 55112 N
85-3.1, Rev.A STATIC CONTROL SYSTEMS TEST STANDARD 22 Aug 1981 TEST: Smear Test Page 2 of 2 LIMITS Acceptable values for smear tests will be set as part of the Test Instructions for each item or device to be tested.
However, some typical limits are as below.
Microcuries Rerrroved Type of Limit 5 x 10-3 NRC Limit 5 x 10-4 Highest acceptable 3M limit (process) 1 x 10-4 Normal limit for acceptance tests (3M) 5 x 10-5 Lower limit of detection for normal counting systems in normal practice When no limit is set,1 x 10-4 microcuries should be used.
Items or devices exceeding these limits shall be rejected or returned to production O
ror re ork-O Prepared By:
Production Quality Plant i*e Supg isi n Supervision Management ff k/,
y t /
e
_ _ _ _